{
"NDC": [
{
"NDCCode": "30142-195-85",
"PackageDescription": "85 g in 1 CAN (30142-195-85) ",
"NDC11Code": "30142-0195-85",
"ProductNDC": "30142-195",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allantoin",
"NonProprietaryName": "Advanced Derma Spray",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180212",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Kroger Co.",
"SubstanceName": "ALLANTOIN",
"StrengthNumber": ".425",
"StrengthUnit": "g/85g",
"Status": "Deprecated",
"LastUpdate": "2024-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180212",
"SamplePackage": "N"
},
{
"NDCCode": "37000-195-85",
"PackageDescription": "85 g in 1 CANISTER (37000-195-85)",
"NDC11Code": "37000-0195-85",
"ProductNDC": "37000-195",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Old Spice High Endurance Clear",
"ProprietaryNameSuffix": "Pure Sport",
"NonProprietaryName": "Aluminum Zirconium Octachlorohydrex Gly",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20020327",
"EndMarketingDate": "20170223",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Procter & Gamble Manufacturing Company",
"SubstanceName": "ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY",
"StrengthNumber": "16",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2017-02-24"
},
{
"NDCCode": "66902-195-03",
"PackageDescription": "85 g in 1 BOTTLE (66902-195-03) ",
"NDC11Code": "66902-0195-03",
"ProductNDC": "66902-195",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Evel Knievels Natural Choice Pain Relief",
"NonProprietaryName": "Menthol, Unspecified Form",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200529",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Natural Essentials, Inc.",
"SubstanceName": "MENTHOL, UNSPECIFIED FORM",
"StrengthNumber": "100",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200529",
"SamplePackage": "N",
"IndicationAndUsage": "Temporary relief of minor aches and pains of muscles and joints associated with: 1 Simple backache, 2 Strains, 3 Sprains, 4 Joint Pain."
},
{
"NDCCode": "30142-053-85",
"PackageDescription": "160 CAPSULE, LIQUID FILLED in 1 BOTTLE (30142-053-85) ",
"NDC11Code": "30142-0053-85",
"ProductNDC": "30142-053",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20190503",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078682",
"LabelerName": "KROGER COMPANY",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2022-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190503",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:. headache. toothache. backache. menstrual cramps. the common cold. muscular aches. minor pain of arthritis. temporarily reduces fever."
},
{
"NDCCode": "30142-180-21",
"PackageDescription": "85 g in 1 TUBE (30142-180-21) ",
"NDC11Code": "30142-0180-21",
"ProductNDC": "30142-180",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Healing",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19880215",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "The Kroger CO.",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "340",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19880215",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily protects: minor cuts, scrapes, burns. temporarily protects and helps relieve chapped or cracked skin and lips. helps protect from the drying effects of wind and cold weather. helps treat and prevent diaper rash. protects chafed skin due to diaper rash and helps seal out wetness."
},
{
"NDCCode": "30142-194-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (30142-194-01) / 85 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "30142-0194-01",
"ProductNDC": "30142-194",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Heartburn Prevention",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077351",
"LabelerName": "Kroger Company",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240521",
"EndMarketingDatePackage": "20260831",
"SamplePackage": "N",
"IndicationAndUsage": "relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages."
},
{
"NDCCode": "30142-251-21",
"PackageDescription": "1 TUBE in 1 CARTON (30142-251-21) > 85 g in 1 TUBE",
"NDC11Code": "30142-0251-21",
"ProductNDC": "30142-251",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arthricream",
"NonProprietaryName": "Trolamine Salicylate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19920204",
"EndMarketingDate": "20241031",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Kroger Company",
"SubstanceName": "TROLAMINE SALICYLATE",
"StrengthNumber": "10",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100521",
"EndMarketingDatePackage": "20241031",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor pain associated with: 1 arthritis , 2 simple backache , 3 muscle strains , 4 sprains , 5 bruises."
},
{
"NDCCode": "30142-270-03",
"PackageDescription": "85 g in 1 CAN (30142-270-03) ",
"NDC11Code": "30142-0270-03",
"ProductNDC": "30142-270",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kroger Anti Itch",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260330",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "The Kroger Co",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20260330",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of itching associated with minor skin irritation and rashes due to eczema, poison ivy, oak, and sumac, cosmetics, jewelry, soaps and detergents, and insect bites. Other uses of this product should be only under the advice and supervision of a doctor."
},
{
"NDCCode": "30142-484-85",
"PackageDescription": "1 BOTTLE in 1 CARTON (30142-484-85) > 250 TABLET in 1 BOTTLE",
"NDC11Code": "30142-0484-85",
"ProductNDC": "30142-484",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pain Relief",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19870715",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Kroger Company",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "30142-544-85",
"PackageDescription": "250 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (30142-544-85) ",
"NDC11Code": "30142-0544-85",
"ProductNDC": "30142-544",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arthritis Pain Relief",
"ProprietaryNameSuffix": "Temporary Minor",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20000606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075077",
"LabelerName": "Kroger Company",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "650",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20130421",
"SamplePackage": "N"
},
{
"NDCCode": "30142-561-85",
"PackageDescription": "1 BOTTLE in 1 CARTON (30142-561-85) > 250 TABLET in 1 BOTTLE",
"NDC11Code": "30142-0561-85",
"ProductNDC": "30142-561",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19870715",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Kroger Company",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2022-11-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19870715",
"SamplePackage": "N"
},
{
"NDCCode": "30142-604-85",
"PackageDescription": "250 TABLET, FILM COATED in 1 BOTTLE (30142-604-85) ",
"NDC11Code": "30142-0604-85",
"ProductNDC": "30142-604",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19880115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072096",
"LabelerName": "Kroger Company",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20050701",
"EndMarketingDatePackage": "20230331",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:. headache . muscular aches . minor pain of arthritis . toothache. backache . the common cold . menstrual cramps. temporarily reduces fever."
},
{
"NDCCode": "30142-692-85",
"PackageDescription": "1 TUBE in 1 CARTON (30142-692-85) > 35 g in 1 TUBE",
"NDC11Code": "30142-0692-85",
"ProductNDC": "30142-692",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cool Heat",
"NonProprietaryName": "Menthol, Methyl Salicylate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100521",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Kroger Company",
"SubstanceName": "MENTHOL; METHYL SALICYLATE",
"StrengthNumber": "10; 30",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2018-04-03",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "30142-730-85",
"PackageDescription": "1 TUBE in 1 CARTON (30142-730-85) > 85 g in 1 TUBE",
"NDC11Code": "30142-0730-85",
"ProductNDC": "30142-730",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kroger Odor Free Arthricream Rub Pain Relieving",
"NonProprietaryName": "Trolamine Salicylate 10%",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220530",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "THE KROGER CO",
"SubstanceName": "TROLAMINE SALICYLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220530",
"SamplePackage": "N",
"IndicationAndUsage": "temporary relieves minor pain associated with: 1 arthritis, 2 simple backache, 3 muscle strains, 4 sprains, 5 bruises, 6 cramps."
},
{
"NDCCode": "30142-917-85",
"PackageDescription": "1 BOTTLE in 1 CARTON (30142-917-85) > 250 CAPSULE, COATED in 1 BOTTLE",
"NDC11Code": "30142-0917-85",
"ProductNDC": "30142-917",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pain Relief",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "CAPSULE, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110401",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Kroger Company",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "16590-195-15",
"PackageDescription": "15 mL in 1 BOTTLE (16590-195-15)",
"NDC11Code": "16590-0195-15",
"ProductNDC": "16590-195",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Proparacaine Hydrochloride",
"NonProprietaryName": "Proparacaine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20000605",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA080027",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "PROPARACAINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Local Anesthesia [PE],Local Anesthetic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Proparacaine hydrochloride ophthalmic solution is indicated for procedures in which a topical ophthalmic anesthetic is indicated: corneal anesthesia of short duration, e.g. tonometry, gonioscopy, removal of corneal foreign bodies, and for short corneal and conjunctival procedures.",
"Description": "Proparacaine hydrochloride ophthalmic solution 0.5% is a topical local anesthetic for ophthalmic use. The active ingredient is represented by the structural formula. Molecular Weight: 330.85. Established name: Proparacaine Hydrochloride. Chemical name: Benzoic acid, 3-amino-4-propoxy-,2-(diethylamino) ethyl ester, monohydrochloride. Each mL contains: Active: proparacaine hydrochloride 5mg 0.5%. Preservative: benzalkonium chloride (0.01%). Inactives: glycerin; and purified water. The pH may be adjusted with hydrochloric acid and/or sodium hydroxide."
},
{
"NDCCode": "70700-113-85",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (70700-113-85) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "70700-0113-85",
"ProductNDC": "70700-113",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isibloom",
"NonProprietaryName": "Desogestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20180201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202789",
"LabelerName": "Xiromed, LLC.",
"Status": "Active",
"LastUpdate": "2023-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230210",
"SamplePackage": "N",
"IndicationAndUsage": "Isibloom (desogestrel and ethinyl estradiol tablets) are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets, 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. aAmong couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. bAmong typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. cAmong couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. dThe treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). eHowever, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. fThe percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. gFoams, creams, gels, vaginal suppositories, and vaginal film. hCervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. iWith spermicidal cream or jelly. jWithout spermicides. Desogestrel and ethinyl estradiol tablets have not been studied for and are not indicated for use in emergency contraception.",
"Description": "Isibloom (desogestrel and ethinyl estradiol tablets, USP) provide an oral contraceptive regimen of 21 orange round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en- 20-yn-17-ol) and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17,diol). Inactive ingredients include alpha-tocopherol, colloidal silicon dioxide, corn starch, FD&C yellow 5 aluminum lake, FD&C yellow 6 aluminum lake, hypromellose 2910, lactose monohydrate, polysorbate, povidone, red iron oxide, stearic acid, titanium dioxide and triacetin. Each green tablet contains the following inactive ingredients: corn starch, colloidal silicon dioxide, FD&C blue 2 aluminum lake, hypromellose 2910, lactose monohydrate, magnesium stearate, polysorbate, povidone, titanium dioxide, triacetin, and yellow iron oxide. USP Dissolution Test 2 used."
},
{
"NDCCode": "0024-2792-10",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (0024-2792-10) / 5 mL in 1 VIAL, SINGLE-USE (0024-2792-01) ",
"NDC11Code": "00024-2792-10",
"ProductNDC": "0024-2792",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ferrlecit",
"NonProprietaryName": "Sodium Ferric Gluconate Complex",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020955",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "SODIUM FERRIC GLUCONATE COMPLEX",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110301",
"SamplePackage": "N",
"IndicationAndUsage": "Ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.",
"Description": "Ferrlecit® (sodium ferric gluconate complex in sucrose injection), an iron replacement product, is a stable macromolecular complex with an apparent molecular weight on gel chromatography of 289,000–440,000 daltons. The macromolecular complex is negatively charged at alkaline pH and is present in solution with sodium cations. The product has a deep red color indicative of ferric oxide linkages. The chemical name is D-Gluconic acid, iron (3+) sodium salt. The structural formula is considered to be [NaFe2O3(C6H11O7)(C12H22011)5]n≈200. Ferrlecit is supplied as a clear, dark brown liquid in colorless glass vials. Each sterile, single-dose vial of 5 mL of Ferrlecit for intravenous injection contains 62.5 mg (12.5 mg/mL) of elemental iron as the sodium salt of a ferric ion carbohydrate complex in an alkaline aqueous solution with approximately 20% sucrose w/v (195 mg/mL) in water for injection, pH 7.7–9.7. Each mL contains 9 mg of benzyl alcohol as an inactive ingredient."
},
{
"NDCCode": "0024-2794-10",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (0024-2794-10) / 5 mL in 1 VIAL, SINGLE-USE (0024-2794-01) ",
"NDC11Code": "00024-2794-10",
"ProductNDC": "0024-2794",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ferrlecit",
"NonProprietaryName": "Sodium Ferric Gluconate Complex",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140707",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020955",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "SODIUM FERRIC GLUCONATE COMPLEX",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140707",
"SamplePackage": "N",
"IndicationAndUsage": "Ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.",
"Description": "Ferrlecit® (sodium ferric gluconate complex in sucrose injection), an iron replacement product, is a stable macromolecular complex with an apparent molecular weight on gel chromatography of 289,000–440,000 daltons. The macromolecular complex is negatively charged at alkaline pH and is present in solution with sodium cations. The product has a deep red color indicative of ferric oxide linkages. The chemical name is D-Gluconic acid, iron (3+) sodium salt. The structural formula is considered to be [NaFe2O3(C6H11O7)(C12H22011)5]n≈200. Ferrlecit is supplied as a clear, dark brown liquid in colorless glass vials. Each sterile, single-dose vial of 5 mL of Ferrlecit for intravenous injection contains 62.5 mg (12.5 mg/mL) of elemental iron as the sodium salt of a ferric ion carbohydrate complex in an alkaline aqueous solution with approximately 20% sucrose w/v (195 mg/mL) in water for injection, pH 7.7–9.7. Each mL contains 9 mg of benzyl alcohol as an inactive ingredient."
},
{
"NDCCode": "0093-3304-16",
"PackageDescription": "6 POUCH in 1 CARTON (0093-3304-16) > 1 BLISTER PACK in 1 POUCH (0093-3304-28) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "00093-3304-16",
"ProductNDC": "0093-3304",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Reclipsen",
"ProprietaryNameSuffix": "28 Day",
"NonProprietaryName": "Desogestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20170101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075256",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Active",
"LastUpdate": "2022-02-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170101",
"SamplePackage": "N",
"IndicationAndUsage": "Reclipsen (desogestrel and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with Reclipsen (desogestrel and ethinyl estradiol tablets USP), 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Table 1: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR. UNITED STATES. Reclipsen (desogestrel and ethinyl estradiol tablets USP) has not been studied for and is not indicated for use in emergency contraception.",
"Description": "Reclipsen (desogestrel and ethinyl estradiol tablets USP) blister cards provide an oral contraceptive regimen of 21 rose-colored, round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol) and 0.03 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Inactive ingredients include colloidal silicon dioxide, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl methylcellulose, lactose monohydrate, polyethylene glycol, polysorbate 80, povidone, pregelatinized corn starch, stearic acid, titanium dioxide, and vitamin E. Reclipsen blister cards also contain 7 white “inactive” tablets for oral administration, containing the following inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Desogestrel. C22H30O M.W. 310.48. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40. The 21 rose-colored tablets meet USP Dissolution Test 2."
},
{
"NDCCode": "0143-9298-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9298-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9298-01) ",
"NDC11Code": "00143-9298-10",
"ProductNDC": "0143-9298",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Ferric Gluconate Complex In Sucrose",
"NonProprietaryName": "Sodium Ferric Gluconate Complex In Sucrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078215",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "SODIUM FERRIC GLUCONATE COMPLEX",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2023-06-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110331",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium ferric gluconate complex in sucrose injection is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.",
"Description": "Sodium ferric gluconate complex in sucrose injection, an iron replacement product, is a stable macromolecular complex with an apparent molecular weight on gel chromatography of 289,000 – 440,000 daltons. The macromolecular complex is negatively charged at alkaline pH and is present in solution with sodium cations. The product has a deep red color indicative of ferric oxide linkages. The chemical name is D-Gluconic acid, iron (3+) sodium salt. The structural formula is considered to be [NaFe2O3(C6H11O7)(C12H22O11)5]n≈200. Each sterile, single dose vial of 5 mL of sodium ferric gluconate complex in sucrose injection for intravenous injection contains 62.5 mg (12.5 mg/mL) of elemental iron as the sodium salt of a ferric ion carbohydrate complex in an alkaline aqueous solution with approximately 20% sucrose w/v (195 mg/mL) in water for injection, pH 7.7 - 9.7. Each mL contains 9 mg of benzyl alcohol as an inactive ingredient."
},
{
"NDCCode": "0143-9570-10",
"PackageDescription": "10 VIAL in 1 CARTON (0143-9570-10) / 5 mL in 1 VIAL (0143-9570-01) ",
"NDC11Code": "00143-9570-10",
"ProductNDC": "0143-9570",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Ferric Gluconate Complex In Sucrose",
"NonProprietaryName": "Sodium Ferric Gluconate Complex In Sucrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078215",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "SODIUM FERRIC GLUCONATE COMPLEX",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110331",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium ferric gluconate complex in sucrose injection is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.",
"Description": "Sodium ferric gluconate complex in sucrose injection, an iron replacement product, is a stable macromolecular complex with an apparent molecular weight on gel chromatography of 289,000 – 440,000 daltons. The macromolecular complex is negatively charged at alkaline pH and is present in solution with sodium cations. The product has a deep red color indicative of ferric oxide linkages. The chemical name is D-Gluconic acid, iron (3+) sodium salt. The structural formula is considered to be [NaFe2O3(C6H11O7)(C12H22O11)5]n≈200. Each sterile, single dose vial of 5 mL of sodium ferric gluconate complex in sucrose injection for intravenous injection contains 62.5 mg (12.5 mg/mL) of elemental iron as the sodium salt of a ferric ion carbohydrate complex in an alkaline aqueous solution with approximately 20% sucrose w/v (195 mg/mL) in water for injection, pH 7.7 - 9.7. Each mL contains 9 mg of benzyl alcohol as an inactive ingredient."
},
{
"NDCCode": "0254-2000-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0254-2000-01) ",
"NDC11Code": "00254-2000-01",
"ProductNDC": "0254-2000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillamine",
"NonProprietaryName": "Penicillamine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211196",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "PENICILLAMINE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antirheumatic Agent [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200102",
"SamplePackage": "N",
"IndicationAndUsage": "Penicillamine tablets are indicated in the treatment of Wilson’s disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy. Available evidence suggests that penicillamine tablets are not of value in ankylosing spondylitis. Wilson’s Disease - Wilson’s disease (hepatolenticular degeneration) results from the interaction of an inherited defect and an abnormality in copper metabolism. The metabolic defect, which is the consequence of the autosomal inheritance of one abnormal gene from each parent, manifests itself in a greater positive copper balance than normal. As a result, copper is deposited in several organs and appears eventually to produce pathologic effects most prominently seen in the brain, where degeneration is widespread; in the liver, where fatty infiltration, inflammation, and hepatocellular damage progress to postnecrotic cirrhosis; in the kidney, where tubular and glomerular dysfunction results; and in the eye, where characteristic corneal copper deposits are known as Kayser-Fleischer rings. Two types of patients require treatment for Wilson’s disease: (1) the symptomatic, and (2) the asymptomatic in whom it can be assumed the disease will develop in the future if the patient is not treated. Diagnosis, suspected on the basis of family or individual history, physical examination, or a low serum concentration of ceruloplasmin*, is confirmed by the demonstration of Kayser-Fleischer rings or, particularly in the asymptomatic patient, by the quantitative demonstration in a liver biopsy specimen of a concentration of copper in excess of 250 mcg/g dry weight. Treatment has two objectives. (1) to minimize dietary intake and absorption of copper. (2) to promote excretion of copper deposited in tissues. The first objective is attained by a daily diet that contains no more than one or two milligrams of copper. Such a diet should exclude, most importantly, chocolate, nuts, shellfish, mushrooms, liver, molasses, broccoli, and cereals enriched with copper, and be composed to as great an extent as possible of foods with a low copper content. Distilled or demineralized water should be used if the patient’s drinking water contains more than 0.1 mg of copper per liter. For the second objective, a copper chelating agent is used. In symptomatic patients, this treatment usually produces marked neurologic improvement, fading of Kayser-Fleischer rings, and gradual amelioration of hepatic dysfunction and psychic disturbances. Clinical experience to date suggests that life is prolonged with the above regimen. Noticeable improvement may not occur for one to three months. Occasionally, neurologic symptoms become worse during initiation of therapy with penicillamine tablets. Despite this, the drug should not be discontinued permanently. Although temporary interruption may result in clinical improvement of the neurological symptoms, it carries an increased risk of developing a sensitivity reaction upon resumption of therapy (See WARNINGS). * For quantitative test for serum ceruloplasmin see: Morell, A.G.; Windsor, J.; Sternlieb, I; Scheinberg, I.H.: Measurement of the concentration of ceruloplasmin in serum by determination of its oxidase activity, in “Laboratory Diagnosis of Liver Disease,” F.W. Sunderman; F.W. Sunderman, Jr., (eds.), St. Louis, Warren H. Green, Inc., 1968, pp. 193-195. Treatment of asymptomatic patients has been carried out for over ten years. Symptoms and signs of the disease appear to be prevented indefinitely if daily treatment with penicillamine tablets can be continued. Cystinuria - Cystinuria is characterized by excessive urinary excretion of the dibasic amino acids, arginine, lysine, ornithine, and cystine, and the mixed disulfide of cysteine and homocysteine. The metabolic defect that leads to cystinuria is inherited as an autosomal, recessive trait. Metabolism of the affected amino acids is influenced by at least two abnormal factors: (1) defective gastrointestinal absorption and (2) renal tubular dysfunction. Arginine, lysine, ornithine, and cysteine are soluble substances, readily excreted. There is no apparent pathology connected with their excretion in excessive quantities. Cystine, however, is so slightly soluble at the usual range of urinary pH that it is not excreted readily, and so crystallizes and forms stones in the urinary tract. Stone formation is the only known pathology in cystinuria. Normal daily output of cystine is 40 to 80 mg. In cystinuria, output is greatly increased and may exceed 1 g/day. At 500 to 600 mg/day, stone formation is almost certain. When it is more than 300 mg/day, treatment is indicated. Conventional treatment is directed at keeping urinary cystine diluted enough to prevent stone formation, keeping the urine alkaline enough to dissolve as much cystine as possible, and minimizing cystine production by a diet low in methionine (the major dietary precursor of cystine). Patients must drink enough fluid to keep urine specific gravity below 1.010, take enough alkali to keep urinary pH at 7.5 to 8, and maintain a diet low in methionine. This diet is not recommended in growing children and probably is contraindicated in pregnancy because of its low protein content (see PRECAUTIONS). When these measures are inadequate to control recurrent stone formation, penicillamine tablets may be used as additional therapy. When patients refuse to adhere to conventional treatment, penicillamine tablets may be a useful substitute. It is capable of keeping cystine excretion to near normal values, thereby hindering stone formation and the serious consequences of pyelonephritis and impaired renal function that develop in some patients. Bartter and colleagues depict the process by which penicillamine interacts with cystine to form penicillamine-cysteine mixed disulfide as. CSSC = cystine. CS' = deprotonated cysteine. PSSP = penicillamine. PS' = deprotonated penicillamine sulfhydryl. CSSP = penicillamine-cysteine mixed disulphide. In this process, it is assumed that the deprotonated form of penicillamine, PS', is the active factor in bringing about the disulfide interchange. Rheumatoid Arthritis - Because penicillamine tablets can cause severe adverse reactions, its use in rheumatoid arthritis should be restricted to patients who have severe, active disease and who have failed to respond to an adequate trial of conventional therapy. Even then, benefit-to-risk ratio should be carefully considered. Other measures, such as rest, physiotherapy, salicylates, and corticosteroids should be used, when indicated, in conjunction with penicillamine tablets (see PRECAUTIONS).",
"Description": "Penicillamine is 3-mercapto-D-valine, a disease modifying antirheumatic drug. It is a white or practically white, crystalline powder, freely soluble in water, slightly soluble in alcohol, and insoluble in ether, acetone, benzene, and carbon tetrachloride. Although its configuration is D, it is levorotatory as usually measured:[α]25° = -62.5° ± 2.0° (C = 1, 1 NNaOH) DThe empirical formula is C5H11NO2S, giving it a molecular weight of 149.21. The structural formula is. It reacts readily with formaldehyde or acetone to form a thiazolidine-carboxylic acid. Penicillamine tablets, USP (Titratable Tablets) for oral administration contain 250 mg of penicillamine. Other ingredients (inactive): anhydrous lactose, copovidone, corn starch (maize), edetate disodium dihydrate, hypromellose, lactose monohydrate, magnesium stearate, magnesium trisilicate, polyethylene glycol, povidone and stearic acid."
},
{
"NDCCode": "0254-2033-73",
"PackageDescription": "3 CARTON in 1 CARTON (0254-2033-73) > 1 BLISTER PACK in 1 CARTON > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "00254-2033-73",
"ProductNDC": "0254-2033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Emoquette",
"NonProprietaryName": "Desogestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20190408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202789",
"LabelerName": "Par Pharmaceutical, Inc.",
"Status": "Deprecated",
"LastUpdate": "2024-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190408",
"SamplePackage": "N",
"IndicationAndUsage": "Emoquette® (desogestrel and ethinyl estradiol tablets) are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets, 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. aAmong couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. bAmong typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. cAmong couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. dThe treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). eHowever, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. fThe percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. gFoams, creams, gels, vaginal suppositories, and vaginal film. hCervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. iWith spermicidal cream or jelly. jWithout spermicides. Desogestrel and ethinyl estradiol tablets have not been studied for and are not indicated for use in emergency contraception.",
"Description": "Emoquette® (desogestrel and ethinyl estradiol tablets, USP) provide an oral contraceptive regimen of 21 orange round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en- 20-yn-17-ol) and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17,diol). Inactive ingredients include alpha-tocopherol, colloidal silicon dioxide, corn starch, FD&C yellow 5 aluminum lake, FD&C yellow 6 aluminum lake, hypromellose 2910, lactose monohydrate, polysorbate, povidone, red iron oxide, stearic acid, titanium dioxide and triacetin. Each green tablet contains the following inactive ingredients: corn starch, colloidal silicon dioxide, FD&C blue 2 aluminum lake, hypromellose 2910, lactose monohydrate, magnesium stearate, polysorbate, povidone, titanium dioxide, triacetin, and yellow iron oxide. USP Dissolution Test 2 used."
},
{
"NDCCode": "0254-2033-80",
"PackageDescription": "6 CARTON in 1 CARTON (0254-2033-80) > 1 BLISTER PACK in 1 CARTON > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "00254-2033-80",
"ProductNDC": "0254-2033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Emoquette",
"NonProprietaryName": "Desogestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20190408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202789",
"LabelerName": "Par Pharmaceutical, Inc.",
"Status": "Deprecated",
"LastUpdate": "2024-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190408",
"SamplePackage": "N",
"IndicationAndUsage": "Emoquette® (desogestrel and ethinyl estradiol tablets) are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets, 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. aAmong couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. bAmong typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. cAmong couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. dThe treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). eHowever, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. fThe percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. gFoams, creams, gels, vaginal suppositories, and vaginal film. hCervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. iWith spermicidal cream or jelly. jWithout spermicides. Desogestrel and ethinyl estradiol tablets have not been studied for and are not indicated for use in emergency contraception.",
"Description": "Emoquette® (desogestrel and ethinyl estradiol tablets, USP) provide an oral contraceptive regimen of 21 orange round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en- 20-yn-17-ol) and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17,diol). Inactive ingredients include alpha-tocopherol, colloidal silicon dioxide, corn starch, FD&C yellow 5 aluminum lake, FD&C yellow 6 aluminum lake, hypromellose 2910, lactose monohydrate, polysorbate, povidone, red iron oxide, stearic acid, titanium dioxide and triacetin. Each green tablet contains the following inactive ingredients: corn starch, colloidal silicon dioxide, FD&C blue 2 aluminum lake, hypromellose 2910, lactose monohydrate, magnesium stearate, polysorbate, povidone, titanium dioxide, triacetin, and yellow iron oxide. USP Dissolution Test 2 used."
},
{
"NDCCode": "0555-9043-58",
"PackageDescription": "6 POUCH in 1 CARTON (0555-9043-58) > 1 BLISTER PACK in 1 POUCH (0555-9043-79) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "00555-9043-58",
"ProductNDC": "0555-9043",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Apri",
"ProprietaryNameSuffix": "28 Day",
"NonProprietaryName": "Desogestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "19991022",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075256",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Active",
"LastUpdate": "2021-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19991022",
"SamplePackage": "N",
"IndicationAndUsage": "Apri® (desogestrel and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with Apri (desogestrel and ethinyl estradiol tablets USP), 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Table 1: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR. UNITED STATES. Apri (desogestrel and ethinyl estradiol tablets USP) has not been studied for and is not indicated for use in emergency contraception.",
"Description": "Apri® (desogestrel and ethinyl estradiol tablets USP) blister cards provide an oral contraceptive regimen of 21 rose-colored, round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol) and 0.03 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Inactive ingredients include colloidal silicon dioxide, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl methylcellulose, lactose monohydrate, polyethylene glycol, polysorbate 80, povidone, pregelatinized corn starch, stearic acid, titanium dioxide, and vitamin E. Apri blister cards also contain 7 white “inactive” tablets for oral administration, containing the following inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Desogestrel. C22H30O M.W. 310.48. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40. The 21 rose-colored tablets meet USP Dissolution Test 2."
},
{
"NDCCode": "10370-195-06",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-195-06) ",
"NDC11Code": "10370-0195-06",
"ProductNDC": "10370-195",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20111004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091360",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20111004",
"SamplePackage": "N",
"IndicationAndUsage": "Extended-release levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy.",
"Description": "Levetiracetam extended-release tablet is an antiepileptic drug available as 500 mg (white) and 750 mg (yellow) extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam extended-release tablets, 500 mg and 750 mg contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc and titanium dioxide. In addition, the 750 mg strength contains iron oxide yellow and iron oxide red. The medication is combined with a drug release controlling polymer that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass."
},
{
"NDCCode": "10370-195-09",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-195-09) ",
"NDC11Code": "10370-0195-09",
"ProductNDC": "10370-195",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20111004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091360",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20111004",
"SamplePackage": "N",
"IndicationAndUsage": "Extended-release levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy.",
"Description": "Levetiracetam extended-release tablet is an antiepileptic drug available as 500 mg (white) and 750 mg (yellow) extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam extended-release tablets, 500 mg and 750 mg contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc and titanium dioxide. In addition, the 750 mg strength contains iron oxide yellow and iron oxide red. The medication is combined with a drug release controlling polymer that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass."
},
{
"NDCCode": "10370-195-50",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-195-50) ",
"NDC11Code": "10370-0195-50",
"ProductNDC": "10370-195",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20111004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091360",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20111004",
"SamplePackage": "N",
"IndicationAndUsage": "Extended-release levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy.",
"Description": "Levetiracetam extended-release tablet is an antiepileptic drug available as 500 mg (white) and 750 mg (yellow) extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam extended-release tablets, 500 mg and 750 mg contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc and titanium dioxide. In addition, the 750 mg strength contains iron oxide yellow and iron oxide red. The medication is combined with a drug release controlling polymer that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass."
},
{
"NDCCode": "10544-195-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (10544-195-90)",
"NDC11Code": "10544-0195-90",
"ProductNDC": "10544-195",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enalapril Maleate",
"NonProprietaryName": "Enalapril Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075657",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "ENALAPRIL MALEATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Enalapril maleate is indicated for the treatment of hypertension. Enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate and thiazides are approximately additive.",
"Description": "Enalapril Maleate is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[ N-[1-(ethoxycarbonyl)-3- phenylpropyl]-L-alanyl]-Lproline, ( Z)-2-butenedioate salt (1:1). Its empirical formula is C 20H 28N 2O 5C 4H 4O 4, and its structural formula is:. Enalapril maleate is a white to off-white, crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin converting enzyme inhibitor. Enalapril maleate is supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, USP, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, pregelatinized starch and sodium bicarbonate. The 2.5 mg, 5 mg and 20 mg tablets also contain iron oxide yellow, and the 10 mg and 20 mg tablets also contain iron oxide red."
}
]
}
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<NDCList>
<NDC>
<NDCCode>30142-195-85</NDCCode>
<PackageDescription>85 g in 1 CAN (30142-195-85) </PackageDescription>
<NDC11Code>30142-0195-85</NDC11Code>
<ProductNDC>30142-195</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allantoin</ProprietaryName>
<NonProprietaryName>Advanced Derma Spray</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180212</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Kroger Co.</LabelerName>
<SubstanceName>ALLANTOIN</SubstanceName>
<StrengthNumber>.425</StrengthNumber>
<StrengthUnit>g/85g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37000-195-85</NDCCode>
<PackageDescription>85 g in 1 CANISTER (37000-195-85)</PackageDescription>
<NDC11Code>37000-0195-85</NDC11Code>
<ProductNDC>37000-195</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Old Spice High Endurance Clear</ProprietaryName>
<ProprietaryNameSuffix>Pure Sport</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Octachlorohydrex Gly</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20020327</StartMarketingDate>
<EndMarketingDate>20170223</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-02-24</LastUpdate>
</NDC>
<NDC>
<NDCCode>66902-195-03</NDCCode>
<PackageDescription>85 g in 1 BOTTLE (66902-195-03) </PackageDescription>
<NDC11Code>66902-0195-03</NDC11Code>
<ProductNDC>66902-195</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Evel Knievels Natural Choice Pain Relief</ProprietaryName>
<NonProprietaryName>Menthol, Unspecified Form</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200529</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Natural Essentials, Inc.</LabelerName>
<SubstanceName>MENTHOL, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporary relief of minor aches and pains of muscles and joints associated with: 1 Simple backache, 2 Strains, 3 Sprains, 4 Joint Pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>30142-053-85</NDCCode>
<PackageDescription>160 CAPSULE, LIQUID FILLED in 1 BOTTLE (30142-053-85) </PackageDescription>
<NDC11Code>30142-0053-85</NDC11Code>
<ProductNDC>30142-053</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190503</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078682</ApplicationNumber>
<LabelerName>KROGER COMPANY</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190503</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:. headache. toothache. backache. menstrual cramps. the common cold. muscular aches. minor pain of arthritis. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>30142-180-21</NDCCode>
<PackageDescription>85 g in 1 TUBE (30142-180-21) </PackageDescription>
<NDC11Code>30142-0180-21</NDC11Code>
<ProductNDC>30142-180</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Healing</ProprietaryName>
<NonProprietaryName>Petrolatum</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19880215</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>The Kroger CO.</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>340</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19880215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily protects: minor cuts, scrapes, burns. temporarily protects and helps relieve chapped or cracked skin and lips. helps protect from the drying effects of wind and cold weather. helps treat and prevent diaper rash. protects chafed skin due to diaper rash and helps seal out wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>30142-194-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (30142-194-01) / 85 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>30142-0194-01</NDC11Code>
<ProductNDC>30142-194</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Heartburn Prevention</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077351</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240521</StartMarketingDatePackage>
<EndMarketingDatePackage>20260831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>30142-251-21</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (30142-251-21) > 85 g in 1 TUBE</PackageDescription>
<NDC11Code>30142-0251-21</NDC11Code>
<ProductNDC>30142-251</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arthricream</ProprietaryName>
<NonProprietaryName>Trolamine Salicylate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19920204</StartMarketingDate>
<EndMarketingDate>20241031</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>TROLAMINE SALICYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100521</StartMarketingDatePackage>
<EndMarketingDatePackage>20241031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor pain associated with: 1 arthritis , 2 simple backache , 3 muscle strains , 4 sprains , 5 bruises.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>30142-270-03</NDCCode>
<PackageDescription>85 g in 1 CAN (30142-270-03) </PackageDescription>
<NDC11Code>30142-0270-03</NDC11Code>
<ProductNDC>30142-270</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kroger Anti Itch</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>The Kroger Co</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of itching associated with minor skin irritation and rashes due to eczema, poison ivy, oak, and sumac, cosmetics, jewelry, soaps and detergents, and insect bites. Other uses of this product should be only under the advice and supervision of a doctor.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>30142-484-85</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (30142-484-85) > 250 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>30142-0484-85</NDC11Code>
<ProductNDC>30142-484</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pain Relief</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19870715</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>30142-544-85</NDCCode>
<PackageDescription>250 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (30142-544-85) </PackageDescription>
<NDC11Code>30142-0544-85</NDC11Code>
<ProductNDC>30142-544</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arthritis Pain Relief</ProprietaryName>
<ProprietaryNameSuffix>Temporary Minor</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000606</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075077</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130421</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>30142-561-85</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (30142-561-85) > 250 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>30142-0561-85</NDC11Code>
<ProductNDC>30142-561</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19870715</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-11-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19870715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>30142-604-85</NDCCode>
<PackageDescription>250 TABLET, FILM COATED in 1 BOTTLE (30142-604-85) </PackageDescription>
<NDC11Code>30142-0604-85</NDC11Code>
<ProductNDC>30142-604</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072096</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050701</StartMarketingDatePackage>
<EndMarketingDatePackage>20230331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:. headache . muscular aches . minor pain of arthritis . toothache. backache . the common cold . menstrual cramps. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>30142-692-85</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (30142-692-85) > 35 g in 1 TUBE</PackageDescription>
<NDC11Code>30142-0692-85</NDC11Code>
<ProductNDC>30142-692</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cool Heat</ProprietaryName>
<NonProprietaryName>Menthol, Methyl Salicylate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100521</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>MENTHOL; METHYL SALICYLATE</SubstanceName>
<StrengthNumber>10; 30</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-04-03</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>30142-730-85</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (30142-730-85) > 85 g in 1 TUBE</PackageDescription>
<NDC11Code>30142-0730-85</NDC11Code>
<ProductNDC>30142-730</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kroger Odor Free Arthricream Rub Pain Relieving</ProprietaryName>
<NonProprietaryName>Trolamine Salicylate 10%</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220530</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>THE KROGER CO</LabelerName>
<SubstanceName>TROLAMINE SALICYLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporary relieves minor pain associated with: 1 arthritis, 2 simple backache, 3 muscle strains, 4 sprains, 5 bruises, 6 cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>30142-917-85</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (30142-917-85) > 250 CAPSULE, COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>30142-0917-85</NDC11Code>
<ProductNDC>30142-917</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pain Relief</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>CAPSULE, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>16590-195-15</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE (16590-195-15)</PackageDescription>
<NDC11Code>16590-0195-15</NDC11Code>
<ProductNDC>16590-195</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Proparacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Proparacaine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20000605</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080027</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>PROPARACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Local Anesthesia [PE],Local Anesthetic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Proparacaine hydrochloride ophthalmic solution is indicated for procedures in which a topical ophthalmic anesthetic is indicated: corneal anesthesia of short duration, e.g. tonometry, gonioscopy, removal of corneal foreign bodies, and for short corneal and conjunctival procedures.</IndicationAndUsage>
<Description>Proparacaine hydrochloride ophthalmic solution 0.5% is a topical local anesthetic for ophthalmic use. The active ingredient is represented by the structural formula. Molecular Weight: 330.85. Established name: Proparacaine Hydrochloride. Chemical name: Benzoic acid, 3-amino-4-propoxy-,2-(diethylamino) ethyl ester, monohydrochloride. Each mL contains: Active: proparacaine hydrochloride 5mg 0.5%. Preservative: benzalkonium chloride (0.01%). Inactives: glycerin; and purified water. The pH may be adjusted with hydrochloric acid and/or sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>70700-113-85</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (70700-113-85) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70700-0113-85</NDC11Code>
<ProductNDC>70700-113</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isibloom</ProprietaryName>
<NonProprietaryName>Desogestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202789</ApplicationNumber>
<LabelerName>Xiromed, LLC.</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isibloom (desogestrel and ethinyl estradiol tablets) are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets, 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. aAmong couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. bAmong typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. cAmong couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. dThe treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). eHowever, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. fThe percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. gFoams, creams, gels, vaginal suppositories, and vaginal film. hCervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. iWith spermicidal cream or jelly. jWithout spermicides. Desogestrel and ethinyl estradiol tablets have not been studied for and are not indicated for use in emergency contraception.</IndicationAndUsage>
<Description>Isibloom (desogestrel and ethinyl estradiol tablets, USP) provide an oral contraceptive regimen of 21 orange round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en- 20-yn-17-ol) and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17,diol). Inactive ingredients include alpha-tocopherol, colloidal silicon dioxide, corn starch, FD&C yellow 5 aluminum lake, FD&C yellow 6 aluminum lake, hypromellose 2910, lactose monohydrate, polysorbate, povidone, red iron oxide, stearic acid, titanium dioxide and triacetin. Each green tablet contains the following inactive ingredients: corn starch, colloidal silicon dioxide, FD&C blue 2 aluminum lake, hypromellose 2910, lactose monohydrate, magnesium stearate, polysorbate, povidone, titanium dioxide, triacetin, and yellow iron oxide. USP Dissolution Test 2 used.</Description>
</NDC>
<NDC>
<NDCCode>0024-2792-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (0024-2792-10) / 5 mL in 1 VIAL, SINGLE-USE (0024-2792-01) </PackageDescription>
<NDC11Code>00024-2792-10</NDC11Code>
<ProductNDC>0024-2792</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ferrlecit</ProprietaryName>
<NonProprietaryName>Sodium Ferric Gluconate Complex</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020955</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>SODIUM FERRIC GLUCONATE COMPLEX</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.</IndicationAndUsage>
<Description>Ferrlecit® (sodium ferric gluconate complex in sucrose injection), an iron replacement product, is a stable macromolecular complex with an apparent molecular weight on gel chromatography of 289,000–440,000 daltons. The macromolecular complex is negatively charged at alkaline pH and is present in solution with sodium cations. The product has a deep red color indicative of ferric oxide linkages. The chemical name is D-Gluconic acid, iron (3+) sodium salt. The structural formula is considered to be [NaFe2O3(C6H11O7)(C12H22011)5]n≈200. Ferrlecit is supplied as a clear, dark brown liquid in colorless glass vials. Each sterile, single-dose vial of 5 mL of Ferrlecit for intravenous injection contains 62.5 mg (12.5 mg/mL) of elemental iron as the sodium salt of a ferric ion carbohydrate complex in an alkaline aqueous solution with approximately 20% sucrose w/v (195 mg/mL) in water for injection, pH 7.7–9.7. Each mL contains 9 mg of benzyl alcohol as an inactive ingredient.</Description>
</NDC>
<NDC>
<NDCCode>0024-2794-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (0024-2794-10) / 5 mL in 1 VIAL, SINGLE-USE (0024-2794-01) </PackageDescription>
<NDC11Code>00024-2794-10</NDC11Code>
<ProductNDC>0024-2794</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ferrlecit</ProprietaryName>
<NonProprietaryName>Sodium Ferric Gluconate Complex</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140707</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020955</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>SODIUM FERRIC GLUCONATE COMPLEX</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140707</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.</IndicationAndUsage>
<Description>Ferrlecit® (sodium ferric gluconate complex in sucrose injection), an iron replacement product, is a stable macromolecular complex with an apparent molecular weight on gel chromatography of 289,000–440,000 daltons. The macromolecular complex is negatively charged at alkaline pH and is present in solution with sodium cations. The product has a deep red color indicative of ferric oxide linkages. The chemical name is D-Gluconic acid, iron (3+) sodium salt. The structural formula is considered to be [NaFe2O3(C6H11O7)(C12H22011)5]n≈200. Ferrlecit is supplied as a clear, dark brown liquid in colorless glass vials. Each sterile, single-dose vial of 5 mL of Ferrlecit for intravenous injection contains 62.5 mg (12.5 mg/mL) of elemental iron as the sodium salt of a ferric ion carbohydrate complex in an alkaline aqueous solution with approximately 20% sucrose w/v (195 mg/mL) in water for injection, pH 7.7–9.7. Each mL contains 9 mg of benzyl alcohol as an inactive ingredient.</Description>
</NDC>
<NDC>
<NDCCode>0093-3304-16</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (0093-3304-16) > 1 BLISTER PACK in 1 POUCH (0093-3304-28) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00093-3304-16</NDC11Code>
<ProductNDC>0093-3304</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Reclipsen</ProprietaryName>
<ProprietaryNameSuffix>28 Day</ProprietaryNameSuffix>
<NonProprietaryName>Desogestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20170101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075256</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2022-02-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Reclipsen (desogestrel and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with Reclipsen (desogestrel and ethinyl estradiol tablets USP), 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Table 1: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR. UNITED STATES. Reclipsen (desogestrel and ethinyl estradiol tablets USP) has not been studied for and is not indicated for use in emergency contraception.</IndicationAndUsage>
<Description>Reclipsen (desogestrel and ethinyl estradiol tablets USP) blister cards provide an oral contraceptive regimen of 21 rose-colored, round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol) and 0.03 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Inactive ingredients include colloidal silicon dioxide, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl methylcellulose, lactose monohydrate, polyethylene glycol, polysorbate 80, povidone, pregelatinized corn starch, stearic acid, titanium dioxide, and vitamin E. Reclipsen blister cards also contain 7 white “inactive” tablets for oral administration, containing the following inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Desogestrel. C22H30O M.W. 310.48. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40. The 21 rose-colored tablets meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>0143-9298-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9298-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9298-01) </PackageDescription>
<NDC11Code>00143-9298-10</NDC11Code>
<ProductNDC>0143-9298</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Ferric Gluconate Complex In Sucrose</ProprietaryName>
<NonProprietaryName>Sodium Ferric Gluconate Complex In Sucrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20110331</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078215</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>SODIUM FERRIC GLUCONATE COMPLEX</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium ferric gluconate complex in sucrose injection is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.</IndicationAndUsage>
<Description>Sodium ferric gluconate complex in sucrose injection, an iron replacement product, is a stable macromolecular complex with an apparent molecular weight on gel chromatography of 289,000 – 440,000 daltons. The macromolecular complex is negatively charged at alkaline pH and is present in solution with sodium cations. The product has a deep red color indicative of ferric oxide linkages. The chemical name is D-Gluconic acid, iron (3+) sodium salt. The structural formula is considered to be [NaFe2O3(C6H11O7)(C12H22O11)5]n≈200. Each sterile, single dose vial of 5 mL of sodium ferric gluconate complex in sucrose injection for intravenous injection contains 62.5 mg (12.5 mg/mL) of elemental iron as the sodium salt of a ferric ion carbohydrate complex in an alkaline aqueous solution with approximately 20% sucrose w/v (195 mg/mL) in water for injection, pH 7.7 - 9.7. Each mL contains 9 mg of benzyl alcohol as an inactive ingredient.</Description>
</NDC>
<NDC>
<NDCCode>0143-9570-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (0143-9570-10) / 5 mL in 1 VIAL (0143-9570-01) </PackageDescription>
<NDC11Code>00143-9570-10</NDC11Code>
<ProductNDC>0143-9570</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Ferric Gluconate Complex In Sucrose</ProprietaryName>
<NonProprietaryName>Sodium Ferric Gluconate Complex In Sucrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20110331</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078215</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>SODIUM FERRIC GLUCONATE COMPLEX</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<IndicationAndUsage>Sodium ferric gluconate complex in sucrose injection is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.</IndicationAndUsage>
<Description>Sodium ferric gluconate complex in sucrose injection, an iron replacement product, is a stable macromolecular complex with an apparent molecular weight on gel chromatography of 289,000 – 440,000 daltons. The macromolecular complex is negatively charged at alkaline pH and is present in solution with sodium cations. The product has a deep red color indicative of ferric oxide linkages. The chemical name is D-Gluconic acid, iron (3+) sodium salt. The structural formula is considered to be [NaFe2O3(C6H11O7)(C12H22O11)5]n≈200. Each sterile, single dose vial of 5 mL of sodium ferric gluconate complex in sucrose injection for intravenous injection contains 62.5 mg (12.5 mg/mL) of elemental iron as the sodium salt of a ferric ion carbohydrate complex in an alkaline aqueous solution with approximately 20% sucrose w/v (195 mg/mL) in water for injection, pH 7.7 - 9.7. Each mL contains 9 mg of benzyl alcohol as an inactive ingredient.</Description>
</NDC>
<NDC>
<NDCCode>0254-2000-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0254-2000-01) </PackageDescription>
<NDC11Code>00254-2000-01</NDC11Code>
<ProductNDC>0254-2000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Penicillamine</ProprietaryName>
<NonProprietaryName>Penicillamine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211196</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>PENICILLAMINE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antirheumatic Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-07</LastUpdate>
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<IndicationAndUsage>Penicillamine tablets are indicated in the treatment of Wilson’s disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy. Available evidence suggests that penicillamine tablets are not of value in ankylosing spondylitis. Wilson’s Disease - Wilson’s disease (hepatolenticular degeneration) results from the interaction of an inherited defect and an abnormality in copper metabolism. The metabolic defect, which is the consequence of the autosomal inheritance of one abnormal gene from each parent, manifests itself in a greater positive copper balance than normal. As a result, copper is deposited in several organs and appears eventually to produce pathologic effects most prominently seen in the brain, where degeneration is widespread; in the liver, where fatty infiltration, inflammation, and hepatocellular damage progress to postnecrotic cirrhosis; in the kidney, where tubular and glomerular dysfunction results; and in the eye, where characteristic corneal copper deposits are known as Kayser-Fleischer rings. Two types of patients require treatment for Wilson’s disease: (1) the symptomatic, and (2) the asymptomatic in whom it can be assumed the disease will develop in the future if the patient is not treated. Diagnosis, suspected on the basis of family or individual history, physical examination, or a low serum concentration of ceruloplasmin*, is confirmed by the demonstration of Kayser-Fleischer rings or, particularly in the asymptomatic patient, by the quantitative demonstration in a liver biopsy specimen of a concentration of copper in excess of 250 mcg/g dry weight. Treatment has two objectives. (1) to minimize dietary intake and absorption of copper. (2) to promote excretion of copper deposited in tissues. The first objective is attained by a daily diet that contains no more than one or two milligrams of copper. Such a diet should exclude, most importantly, chocolate, nuts, shellfish, mushrooms, liver, molasses, broccoli, and cereals enriched with copper, and be composed to as great an extent as possible of foods with a low copper content. Distilled or demineralized water should be used if the patient’s drinking water contains more than 0.1 mg of copper per liter. For the second objective, a copper chelating agent is used. In symptomatic patients, this treatment usually produces marked neurologic improvement, fading of Kayser-Fleischer rings, and gradual amelioration of hepatic dysfunction and psychic disturbances. Clinical experience to date suggests that life is prolonged with the above regimen. Noticeable improvement may not occur for one to three months. Occasionally, neurologic symptoms become worse during initiation of therapy with penicillamine tablets. Despite this, the drug should not be discontinued permanently. Although temporary interruption may result in clinical improvement of the neurological symptoms, it carries an increased risk of developing a sensitivity reaction upon resumption of therapy (See WARNINGS). * For quantitative test for serum ceruloplasmin see: Morell, A.G.; Windsor, J.; Sternlieb, I; Scheinberg, I.H.: Measurement of the concentration of ceruloplasmin in serum by determination of its oxidase activity, in “Laboratory Diagnosis of Liver Disease,” F.W. Sunderman; F.W. Sunderman, Jr., (eds.), St. Louis, Warren H. Green, Inc., 1968, pp. 193-195. Treatment of asymptomatic patients has been carried out for over ten years. Symptoms and signs of the disease appear to be prevented indefinitely if daily treatment with penicillamine tablets can be continued. Cystinuria - Cystinuria is characterized by excessive urinary excretion of the dibasic amino acids, arginine, lysine, ornithine, and cystine, and the mixed disulfide of cysteine and homocysteine. The metabolic defect that leads to cystinuria is inherited as an autosomal, recessive trait. Metabolism of the affected amino acids is influenced by at least two abnormal factors: (1) defective gastrointestinal absorption and (2) renal tubular dysfunction. Arginine, lysine, ornithine, and cysteine are soluble substances, readily excreted. There is no apparent pathology connected with their excretion in excessive quantities. Cystine, however, is so slightly soluble at the usual range of urinary pH that it is not excreted readily, and so crystallizes and forms stones in the urinary tract. Stone formation is the only known pathology in cystinuria. Normal daily output of cystine is 40 to 80 mg. In cystinuria, output is greatly increased and may exceed 1 g/day. At 500 to 600 mg/day, stone formation is almost certain. When it is more than 300 mg/day, treatment is indicated. Conventional treatment is directed at keeping urinary cystine diluted enough to prevent stone formation, keeping the urine alkaline enough to dissolve as much cystine as possible, and minimizing cystine production by a diet low in methionine (the major dietary precursor of cystine). Patients must drink enough fluid to keep urine specific gravity below 1.010, take enough alkali to keep urinary pH at 7.5 to 8, and maintain a diet low in methionine. This diet is not recommended in growing children and probably is contraindicated in pregnancy because of its low protein content (see PRECAUTIONS). When these measures are inadequate to control recurrent stone formation, penicillamine tablets may be used as additional therapy. When patients refuse to adhere to conventional treatment, penicillamine tablets may be a useful substitute. It is capable of keeping cystine excretion to near normal values, thereby hindering stone formation and the serious consequences of pyelonephritis and impaired renal function that develop in some patients. Bartter and colleagues depict the process by which penicillamine interacts with cystine to form penicillamine-cysteine mixed disulfide as. CSSC = cystine. CS' = deprotonated cysteine. PSSP = penicillamine. PS' = deprotonated penicillamine sulfhydryl. CSSP = penicillamine-cysteine mixed disulphide. In this process, it is assumed that the deprotonated form of penicillamine, PS', is the active factor in bringing about the disulfide interchange. Rheumatoid Arthritis - Because penicillamine tablets can cause severe adverse reactions, its use in rheumatoid arthritis should be restricted to patients who have severe, active disease and who have failed to respond to an adequate trial of conventional therapy. Even then, benefit-to-risk ratio should be carefully considered. Other measures, such as rest, physiotherapy, salicylates, and corticosteroids should be used, when indicated, in conjunction with penicillamine tablets (see PRECAUTIONS).</IndicationAndUsage>
<Description>Penicillamine is 3-mercapto-D-valine, a disease modifying antirheumatic drug. It is a white or practically white, crystalline powder, freely soluble in water, slightly soluble in alcohol, and insoluble in ether, acetone, benzene, and carbon tetrachloride. Although its configuration is D, it is levorotatory as usually measured:[α]25° = -62.5° ± 2.0° (C = 1, 1 NNaOH) DThe empirical formula is C5H11NO2S, giving it a molecular weight of 149.21. The structural formula is. It reacts readily with formaldehyde or acetone to form a thiazolidine-carboxylic acid. Penicillamine tablets, USP (Titratable Tablets) for oral administration contain 250 mg of penicillamine. Other ingredients (inactive): anhydrous lactose, copovidone, corn starch (maize), edetate disodium dihydrate, hypromellose, lactose monohydrate, magnesium stearate, magnesium trisilicate, polyethylene glycol, povidone and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>0254-2033-73</NDCCode>
<PackageDescription>3 CARTON in 1 CARTON (0254-2033-73) > 1 BLISTER PACK in 1 CARTON > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00254-2033-73</NDC11Code>
<ProductNDC>0254-2033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Emoquette</ProprietaryName>
<NonProprietaryName>Desogestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20190408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202789</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190408</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Emoquette® (desogestrel and ethinyl estradiol tablets) are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets, 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. aAmong couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. bAmong typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. cAmong couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. dThe treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). eHowever, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. fThe percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. gFoams, creams, gels, vaginal suppositories, and vaginal film. hCervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. iWith spermicidal cream or jelly. jWithout spermicides. Desogestrel and ethinyl estradiol tablets have not been studied for and are not indicated for use in emergency contraception.</IndicationAndUsage>
<Description>Emoquette® (desogestrel and ethinyl estradiol tablets, USP) provide an oral contraceptive regimen of 21 orange round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en- 20-yn-17-ol) and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17,diol). Inactive ingredients include alpha-tocopherol, colloidal silicon dioxide, corn starch, FD&C yellow 5 aluminum lake, FD&C yellow 6 aluminum lake, hypromellose 2910, lactose monohydrate, polysorbate, povidone, red iron oxide, stearic acid, titanium dioxide and triacetin. Each green tablet contains the following inactive ingredients: corn starch, colloidal silicon dioxide, FD&C blue 2 aluminum lake, hypromellose 2910, lactose monohydrate, magnesium stearate, polysorbate, povidone, titanium dioxide, triacetin, and yellow iron oxide. USP Dissolution Test 2 used.</Description>
</NDC>
<NDC>
<NDCCode>0254-2033-80</NDCCode>
<PackageDescription>6 CARTON in 1 CARTON (0254-2033-80) > 1 BLISTER PACK in 1 CARTON > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00254-2033-80</NDC11Code>
<ProductNDC>0254-2033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Emoquette</ProprietaryName>
<NonProprietaryName>Desogestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20190408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202789</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190408</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Emoquette® (desogestrel and ethinyl estradiol tablets) are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets, 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. aAmong couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. bAmong typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. cAmong couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. dThe treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). eHowever, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. fThe percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. gFoams, creams, gels, vaginal suppositories, and vaginal film. hCervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. iWith spermicidal cream or jelly. jWithout spermicides. Desogestrel and ethinyl estradiol tablets have not been studied for and are not indicated for use in emergency contraception.</IndicationAndUsage>
<Description>Emoquette® (desogestrel and ethinyl estradiol tablets, USP) provide an oral contraceptive regimen of 21 orange round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en- 20-yn-17-ol) and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17,diol). Inactive ingredients include alpha-tocopherol, colloidal silicon dioxide, corn starch, FD&C yellow 5 aluminum lake, FD&C yellow 6 aluminum lake, hypromellose 2910, lactose monohydrate, polysorbate, povidone, red iron oxide, stearic acid, titanium dioxide and triacetin. Each green tablet contains the following inactive ingredients: corn starch, colloidal silicon dioxide, FD&C blue 2 aluminum lake, hypromellose 2910, lactose monohydrate, magnesium stearate, polysorbate, povidone, titanium dioxide, triacetin, and yellow iron oxide. USP Dissolution Test 2 used.</Description>
</NDC>
<NDC>
<NDCCode>0555-9043-58</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (0555-9043-58) > 1 BLISTER PACK in 1 POUCH (0555-9043-79) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00555-9043-58</NDC11Code>
<ProductNDC>0555-9043</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Apri</ProprietaryName>
<ProprietaryNameSuffix>28 Day</ProprietaryNameSuffix>
<NonProprietaryName>Desogestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19991022</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075256</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2021-12-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19991022</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apri® (desogestrel and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with Apri (desogestrel and ethinyl estradiol tablets USP), 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Table 1: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR. UNITED STATES. Apri (desogestrel and ethinyl estradiol tablets USP) has not been studied for and is not indicated for use in emergency contraception.</IndicationAndUsage>
<Description>Apri® (desogestrel and ethinyl estradiol tablets USP) blister cards provide an oral contraceptive regimen of 21 rose-colored, round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol) and 0.03 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Inactive ingredients include colloidal silicon dioxide, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl methylcellulose, lactose monohydrate, polyethylene glycol, polysorbate 80, povidone, pregelatinized corn starch, stearic acid, titanium dioxide, and vitamin E. Apri blister cards also contain 7 white “inactive” tablets for oral administration, containing the following inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Desogestrel. C22H30O M.W. 310.48. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40. The 21 rose-colored tablets meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>10370-195-06</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-195-06) </PackageDescription>
<NDC11Code>10370-0195-06</NDC11Code>
<ProductNDC>10370-195</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091360</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Extended-release levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy.</IndicationAndUsage>
<Description>Levetiracetam extended-release tablet is an antiepileptic drug available as 500 mg (white) and 750 mg (yellow) extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam extended-release tablets, 500 mg and 750 mg contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc and titanium dioxide. In addition, the 750 mg strength contains iron oxide yellow and iron oxide red. The medication is combined with a drug release controlling polymer that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass.</Description>
</NDC>
<NDC>
<NDCCode>10370-195-09</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-195-09) </PackageDescription>
<NDC11Code>10370-0195-09</NDC11Code>
<ProductNDC>10370-195</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091360</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Extended-release levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy.</IndicationAndUsage>
<Description>Levetiracetam extended-release tablet is an antiepileptic drug available as 500 mg (white) and 750 mg (yellow) extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam extended-release tablets, 500 mg and 750 mg contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc and titanium dioxide. In addition, the 750 mg strength contains iron oxide yellow and iron oxide red. The medication is combined with a drug release controlling polymer that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass.</Description>
</NDC>
<NDC>
<NDCCode>10370-195-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-195-50) </PackageDescription>
<NDC11Code>10370-0195-50</NDC11Code>
<ProductNDC>10370-195</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091360</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Extended-release levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy.</IndicationAndUsage>
<Description>Levetiracetam extended-release tablet is an antiepileptic drug available as 500 mg (white) and 750 mg (yellow) extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam extended-release tablets, 500 mg and 750 mg contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc and titanium dioxide. In addition, the 750 mg strength contains iron oxide yellow and iron oxide red. The medication is combined with a drug release controlling polymer that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass.</Description>
</NDC>
<NDC>
<NDCCode>10544-195-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (10544-195-90)</PackageDescription>
<NDC11Code>10544-0195-90</NDC11Code>
<ProductNDC>10544-195</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enalapril Maleate</ProprietaryName>
<NonProprietaryName>Enalapril Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075657</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>ENALAPRIL MALEATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Enalapril maleate is indicated for the treatment of hypertension. Enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate and thiazides are approximately additive.</IndicationAndUsage>
<Description>Enalapril Maleate is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[ N-[1-(ethoxycarbonyl)-3- phenylpropyl]-L-alanyl]-Lproline, ( Z)-2-butenedioate salt (1:1). Its empirical formula is C 20H 28N 2O 5C 4H 4O 4, and its structural formula is:. Enalapril maleate is a white to off-white, crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin converting enzyme inhibitor. Enalapril maleate is supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, USP, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, pregelatinized starch and sodium bicarbonate. The 2.5 mg, 5 mg and 20 mg tablets also contain iron oxide yellow, and the 10 mg and 20 mg tablets also contain iron oxide red.</Description>
</NDC>
</NDCList>